Annular Adhesive Structure

ABSTRACT

An assembly for joining tissue is provided and includes an anvil assembly and a body portion juxtaposed with respect to one another along a shaft and arranged so as to be approximated with respect to one another; and an applicator supported on the anvil assembly and configured for retaining a wound treatment material therein and for dispensing the wound treatment material therefrom. A method for joining tissue is provided and includes the steps of dispensing the wound treatment material from the applicator so as to distribute wound treatment material onto at least one of a first tissue section and a second tissue section; and approximating the anvil assembly and the body portion to one another so that the first tissue section and the second tissue section are in contact with one another with the dispensed wound treatment material interposed therebetween.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation-in-Part Application whichclaims the benefit of and priority to U.S. application Ser. No.11/248,846, filed on Oct. 12, 2005, which claims the benefit of andpriority to U.S. Provisional Application 60/620,268, filed on Oct. 18,2004; U.S. Provisional Application 60/620,269, filed on Oct. 18, 2004;U.S. Provisional Application 60/620,066, filed on Oct. 18, 2004; U.S.Provisional Application 60/620,140, filed on Oct. 18, 2004, and U.S.Provisional Application 60/669,104, filed on Apr. 7, 2005; the entiredisclosure of each of which being incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to devices and methods for applyingcompositions including wound treatment materials, adhesives and/orsealing compositions, for use with or without stapling devices, forjoining tissue, and for reducing occurrences of leaking, bleeding and/orstricture.

2. Background of Related Art

Throughout the years the medical field has utilized various techniquesin an effort to join or bond body tissue together. Historically,suturing was the accepted technique for rejoining severed tissues andclosing wounds. Suturing was achieved with a surgical needle and asuturing thread, and more recently, with a variety of polymeric ormetallic staples, as will be discussed below. The intended function ofsutures is to hold the edges of a wound or tissue against one anotherduring the healing process so as to reduce discomfort, pain, scarringand the time required for healing.

Recently, many procedures which in the past required conventionalsuturing have been replaced by staple suturing which involves theapplication of the staples to the edges of the wound or tissue with theuse of a surgical stapler. Surgical staplers have been developed forjoining adjacent tissue, for providing hemostasis of adjacent tissue andfor providing hemostasis in conjunction with cutting of adjacent tissue.Such surgical staplers include both linear and annular typeconfigurations. A typical linear stapler and cutter includes parallelrows of staples with a slot for a cutting means to travel between therows of staples.

Staples have traditionally been used to replace suturing when joining oranastomosing various body structures, such as, for example, the bowel orbronchus. The surgical stapling devices employed to apply these staplesare generally designed to simultaneously cut and join an extendedsegment of tissue in a patient, thus vastly reducing the time and risksof such procedures.

Linear or annular surgical stapling devices are employed by surgeons tosequentially or simultaneously apply one or more rows of surgicalfasteners, e.g., staples or two-part fasteners, to body tissue for thepurpose of joining segments of body tissue together and/or for thecreation of anastomoses. Linear surgical stapling devices generallyinclude a pair of jaws or finger-like structures between which bodytissue to be joined is placed. When the surgical stapling device isactuated and/or “fired”, firing bars move longitudinally and contactstaple drive members in one of the jaws, and surgical staples are pushedthrough the body tissue and into/against an anvil in the opposite jawthereby crimping the staples closed. A knife blade may be provided tocut between the rows/lines of staples. Examples of such surgicalstapling devices are described in U.S. Pat. Nos. 4,354,628, 5,014,899and 5,040,715, the entirety of each of which is incorporated herein byreference.

Annular surgical stapling devices generally include an annular staplecartridge assembly including a plurality of annular rows of staples,typically two, an anvil assembly operatively associated with the annularcartridge assembly, and an annular blade disposed internal of the rowsof staples. Examples of such annular surgical stapling devices aredescribed in U.S. Pat. Nos. 5,799,857 and 5,915,616 to Robertson et al.,the entirety of each of which is incorporated herein by reference.

For most procedures, the use of bare staples, with the staples in directcontact with the patient's tissue, is generally acceptable. Theintegrity of the tissue will normally serve to prevent the staples fromtearing out of the tissue and compromising the sealing before healinghas occurred. However, in some surgical operations, surgical supports,e.g., meshes, are employed by surgeons to bridge, repair and/orreinforce tissue defects with a patient, especially those occurring inthe abdominal wall, chest wall, diaphragm and other musculo-aponeuroticareas of the body. Examples of surgical supports are disclosed in U.S.Pat. Nos. 3,054,406, 3,124,136, 4,347,847, 4,655,221, 4,838,884 and5,002,551, the entirety of each of which is incorporated herein byreference.

When the staples are applied in surgical procedures utilizing surgicalmeshes, supports, buttresses and the like (i.e., reinforcing material),the legs of the staple typically pass from the cartridge jaw through alayer of the surgical support, and through the patient's tissue beforeencountering the anvil jaw. In an alternative procedure, the legs of thestaple typically pass from the cartridge jaw through a first layer ofthe surgical support, then through the patient's tissue, and finallythrough a second layer of the surgical support before encountering theanvil jaw. With the staples in place, the stapled tissue is clampedbetween the layers of the surgical support. Reference may be made toU.S. Pat. No. 5,542,594, the entire content of which is incorporatedherein by reference, for a more detailed discussion of the use ofsurgical supports in cooperation with surgical stapling instrument.

In addition to the use of surgical staples, biological tissue adhesiveshave been developed for joining tissue. Generally, biological adhesivesbond separated tissues together. Such adhesives may be used instead ofsuturing and stapling, for example, in surgical procedures, for therepair of tissue or the creation of anastomoses.

In addition to the use of biological adhesives, following the formationof the anastomosis, a separate instrument or device is used to applybiological sealants to the outer surface of the anastomosis. Typically,in a separate step, the biological sealants are applied to the outersurface of the anastomosis. The biological sealants are intended toreduce and/or stop the incidents of leakage from the anastomosis.

One possible side effect of any end-to-end bowel anastomosis is itstendency to stenos over time, which stenosis can decrease the diameterof the lumen over time. Accordingly, the need exists for a surgicalsupport structure which operates in conjunction with any end-to-endanastomosis device and assists in maintaining the lumen of theanastomosed bowel or other tubular organ open over time.

The application of suitable biocompatible adhesive offers manyadvantages to the patient and the surgeon alike, such as, for example,the possible reduction in the number of staples used, immediate sealingof the tissue being treated, a strengthening of the anastomosis, and areduction in the occurrence of bleeding from the blood vessels, leakagethrough the tissue joint, and stricture. Moreover, use of biocompatibleadhesives tends to minimize foreign body reaction and scarring.

There is a need for surgical stapling instruments and devices, whichreduce the trauma suffered by a patient, reduce the number of gapsbetween or at individual staple sites, reduce leakage of fluids, reducebleeding, and/or which create a relatively strong bond between adjacentbody tissues, e.g., along staple lines and tissue seams.

Accordingly, the need exists for devices for applying structures andcompositions which operate with or without surgical staples to assist inmaintaining the joined tissue, including maintaining the tubular organspatent or open over time.

A need also exists for structures which operate with or without surgicalstaples to reduce the trauma suffered by the patient, reduce theinstances of leakage, reduce the instances of bleeding, and create arelatively strong bond between adjacent body tissues.

SUMMARY

The present disclosure relates to devices and methods for applying woundtreatment materials for use with or without stapling devices, forjoining tissue, and for reducing occurrences of leaking, bleeding and/orstricture.

According to an aspect of the present disclosure, an assembly forjoining tissue is provided and includes an anvil assembly and a bodyportion juxtaposed with respect to one another along a shaft andarranged so as to be approximated with respect to one another; and anapplicator supported on the anvil assembly and configured for retaininga wound treatment material therein and for dispensing the woundtreatment material therefrom.

The applicator may include a sleeve operatively connected to the anvilassembly, wherein the wound treatment material is retained within anddispensed from the sleeve. The applicator may further include an ampouleselectively positionable within the sleeve, wherein the wound treatmentmaterial is retained within and dispensed from the ampoule. Theapplicator may still further include a manifold supported on the anvilassembly, wherein the manifold defines at least one channel therein fordirecting a flow of wound treatment material. The manifold may besupported on the shaft.

Each channel of the manifold may be in fluid communication with thesleeve and the ampoule. The manifold may extend radially outward fromthe shaft and wherein each channel formed therein is radially oriented.

The applicator may include a seal interposed between the sleeve and theampoule. The applicator and the shaft may be complementarily configuredfor bayonet-type coupling therebetween.

The body portion may carry a plurality of surgical staples in an annularconfiguration. The surgical staples may be deployable against the anvil.The assembly may further include an annular knife disposed radiallyinwardly of the staples.

According to another aspect of the present disclosure, a method ofjoining tissue is provided. The method includes the steps of providingan apparatus having an anvil assembly including a stem; an applicatorsupported on the stem of the anvil assembly and configured for retaininga wound treatment material therein and for dispensing the woundtreatment material therefrom; and a body portion in juxtaposition to theanvil assembly and arranged so as to be approximated with respect to theanvil assembly.

The method further includes the steps of dispensing the wound treatmentmaterial from the applicator so as to distribute wound treatmentmaterial onto at least one of a first tissue section and a second tissuesection; and approximating the anvil assembly and the body portion toone another so that the first tissue section and the second tissuesection are in contact with one another with the dispensed woundtreatment material interposed therebetween.

The wound treatment material may be at least one of an adhesive, asealant, a hemostat, and a medicament.

The applicator may include a sleeve operatively connected to the anvilassembly; an ampoule selectively positionable within the sleeve, whereinthe wound treatment material is retained within and dispensed from theampoule; and a manifold supported on the anvil assembly, wherein themanifold defines at least one channel therein for directing a flow ofwound treatment material. The method may further include the step ofdispensing the wound treatment material from the ampoule and out througheach channel.

The manifold may extend radially outward from the stem of the anvilassembly and each channel formed therein may be radially oriented. Theapplicator may include a seal interposed between the sleeve and theampoule.

The method may further include the step of dispensing the woundtreatment material in a radially outward direction. The method mayinclude the step of dispensing the wound treatment material from atleast one channel of the manifold. The method may further include thestep of dispensing the wound treatment material from the ampoule and outthrough at least one channel of the manifold.

The body portion may include a connection member. Accordingly, theapplicator and the connection member may be complementarily configuredfor bayonet-type coupling therebetween.

The body portion may carry a plurality of surgical staples in an annularconfiguration wherein the surgical staples are deployable against theanvil assembly. The method may further include the step of stapling thefirst tissue section to the second tissue section.

The apparatus may further include an annular knife disposed radiallyinwardly of the staples. Accordingly, the method may further include thestep of severing the first and second tissue sections at a locationradially inward of the staples.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given aboveand the detailed description of the embodiments given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1 is a perspective view of an exemplary annular surgical staplingdevice;

FIG. 2 is a perspective view of a support structure in accordance withan embodiment of the present disclosure, for use with the annularsurgical stapling device of FIG. 1;

FIG. 3 is a cross-sectional view of a support structure in accordancewith an alternate embodiment of the present disclosure, as taken through3-3 of FIG. 2, for use with the annular surgical stapling device of FIG.1;

FIG. 4 is a perspective view of a support structure in accordance withanother embodiment of the present disclosure, for use with the annularsurgical stapling device of FIG. 1;

FIG. 5 is a perspective view of a support structure in accordance withyet another embodiment of the present disclosure, for use with theannular surgical stapling device of FIG. 1;

FIG. 6 is an exploded perspective view of the support structure of FIG.5;

FIG. 7 is a cross-sectional view of the support structure of FIGS. 5 and6, as taken through 7-7 of FIG. 5;

FIG. 8 is a perspective view of the intestinal area of a patient,illustrating a method of positioning any of the support structures ofFIGS. 2-7 on the anvil rod of the annular stapling device of FIG. 1;

FIG. 9 is a schematic perspective view of the intestinal area of FIG. 8,illustrating the anvil rod mounted to the annular stapling device andhaving any of the support structure of FIGS. 2-7 disposed therebetween;

FIG. 10 is a perspective view of a support structure, according toanother embodiment of the present disclosure, shown in an undeployedcondition;

FIG. 11 is a cross-sectional view of the support structure of FIG. 10,as taken through 11-11 of FIG. 10;

FIG. 12 is a perspective view of the support structure of FIGS. 10 and11, shown in a deployed condition;

FIG. 13 is a cross-sectional view of the support structure of FIGS.10-12;

FIG. 14 is a longitudinal cross-sectional view illustrating the anvilrod mounted to the annular stapling device within a surgical site andthe support structure of FIGS. 10-13, in an undeployed condition,disposed between the apposed surfaces of the tissue;

FIG. 15 is a longitudinal cross-sectional view illustrating the anvilrod mounted to the annular stapling device within a surgical site andthe support structure of FIGS. 10-13, in a deployed condition, disposedbetween the apposed surfaces of the tissue;

FIG. 16 is a perspective view of an support structure according to analternate embodiment of the present disclosure;

FIG. 17 is a cross-sectional view of the support structure of FIG. 16,as taken through 17-17 of FIG. 16;

FIG. 18 is an enlarged view of the indicated area of detail of FIG. 17;

FIG. 19 is a longitudinal cross-sectional view illustrating the anvilrod mounted to the annular stapling device within a surgical site andthe support structure of FIGS. 16-18, in an undeployed condition,disposed between the apposed surfaces of the tissue;

FIG. 20 is a longitudinal cross-sectional view illustrating the anvilrod mounted to the annular stapling device within a surgical site andthe support structure of FIGS. 16-18, in a deployed condition, disposedbetween the apposed surfaces of the tissue;

FIG. 21 is a perspective view of a support structure according to yetanother alternate embodiment of the present disclosure;

FIG. 22 is a perspective view of an anvil assembly including a supportstructure assembly, according to another embodiment of the presentdisclosure, shown in a first condition;

FIG. 23 is a longitudinal cross-sectional view of the support structureassembly of FIG. 22;

FIG. 24 is a perspective view of the support structure assembly of FIGS.22 and 23, shown in a second condition;

FIG. 25 is a longitudinal cross-sectional view of the support structureof FIG. 24;

FIG. 26 is a perspective view of a support structure for use with theassembly of FIGS. 22-25;

FIG. 27 is a cross-sectional view of the support structure of FIG. 26,as taken through 27-27 of FIG. 26;

FIG. 28 is an exploded perspective view of the support structure ofFIGS. 26 and 27;

FIG. 29 is a longitudinal cross-sectional view of a distal end of thesurgical stapling apparatus while disposed in an operative site,illustrating the support structure of FIGS. 22-28, while in the firstcondition; and

FIG. 30 is a longitudinal cross-sectional view of a distal end of thesurgical stapling apparatus while disposed in an operative site,illustrating the support structure of FIGS. 22-28, while in the secondcondition;

FIG. 31 illustrates a perspective view of a surgical stapling apparatusaccording to another embodiment of the present disclosure;

FIG. 32 is a perspective view, with parts separated, of the anvil memberof the surgical stapling apparatus of FIG. 31 including a supportstructure, in accordance with the present disclosure;

FIG. 33 is a perspective view of the support structure of FIG. 32,illustrated in an expanded condition;

FIG. 34 is a cross-sectional view of the support structure of FIG. 33,as taken through 34-34 of FIG. 33;

FIG. 35 is a side elevational view of a distal end of the surgicalstapling apparatus of FIG. 31, shown positioned in the operative site,illustrating the support structure of FIGS. 32-35 in a first or deflatedcondition;

FIG. 36 is a side elevational view of the distal end of the surgicalstapling apparatus of FIG. 31, shown positioned in the operative site,illustrating the support structure of FIGS. 32-34 in a second orinflated condition in order to dispense wound treatment material ontothe surface of the tissue to be anastomosed;

FIG. 37 is a side elevational view of the distal end of the surgicalstapling apparatus of FIG. 31, shown positioned in the operative site,illustrating the wound treatment applying structure of FIGS. 32-34 in athird or deflated condition following dispensing of the wound treatmentmaterial onto the surface of the tissue to be anastomosed;

FIG. 38 is a perspective view of a support structure in accordance withanother embodiment of the present disclosure, in an expanded condition,for use with the annular surgical stapling device of FIG. 31;

FIG. 39 is a cross-sectional view of the support structure of FIG. 38,as taken through 39-39 of FIG. 38;

FIG. 40 is a top plan view of a support structure in accordance withanother embodiment of the present disclosure, shown in a deployedcondition;

FIG. 41 is a cross-sectional view of the support structure of FIG. 40 astaken through 41-41 of FIG. 40;

FIG. 42 is a perspective view of a support structure, according to yetanother embodiment of the present disclosure, shown in a collapsed ordeflated condition;

FIG. 43 is a perspective view of the support structure of FIG. 42 beingfilled or inflated from a remote source of fluid;

FIG. 44 is a perspective view of the support structure of FIGS. 42 and43, shown in a filled or inflated condition;

FIG. 45 is an enlarged perspective view of the distal end of thesurgical stapling apparatus illustrating an anvil assembly including anapplicator operatively connected thereto; and

FIG. 46 is an enlarged perspective view of a distal end of the anvilassembly of FIG. 45.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed devices and structures will nowbe described in detail with reference to the drawing figures whereinlike reference numerals identify similar or identical elements. As usedherein and as is traditional, the term “distal” refers to that portionwhich is furthest from the user while the term “proximal” refers to thatportion which is closest to the user.

Referring initially to FIG. 1, an annular surgical stapling device, foruse with the annular adhesive structures disclosed herein, is generallydesignated as 10. Surgical stapling device 10 includes a handle assembly12 having at least one pivotable actuating handle member 14, and anadvancing member 16. Extending from handle member 12, there is provideda tubular body portion 20 which may be constructed so as to have acurved shape along its length. Body portion 20 terminates in a staplecartridge assembly 22 which includes one or more arrays of staplereceiving slots 36 having a staple (not shown) disposed in each one ofstaple receiving slots 36. Typically, a pair of annular arrays of staplereceiving slots 36 is provided. Positioned distally of staple cartridgeassembly 22 there is provided an anvil assembly 30 including an anvilmember 26 and a shaft 28 operatively associated therewith for removablyconnecting anvil assembly 30 to a distal end portion or connectionmember 40 of stapling device 10.

Staple cartridge assembly 22 may be fixedly connected to the distal endof tubular body portion 20 or may be configured to concentrically fitwithin the distal end of tubular body portion 20. Typically, staplecartridge assembly 22 includes a staple pusher (not shown) including aproximal portion having a generally frusto-conical shape and a distalportion defining two concentric rings of peripherally spaced fingers(not shown), each one of which is received within a respective staplereceiving slot 36.

Typically, a knife (not shown), substantially in the form of an open cupwith the rim thereof defining a knife edge, is disposed within staplecartridge assembly 22 and mounted to a distal surface of the staplepusher (not shown). The knife edge is disposed radially inward of thepair of annular arrays of staples. Accordingly, in use, as the staplepusher is advanced, the knife is also advanced axially outward.

Reference may be made to U.S. Pat. No. 5,915,616 to Viola et al., theentire content of which is incorporated herein by reference, for adetailed discussion of annular stapling device 10. Although a circularstapling apparatus is shown in FIG. 1, the stapling device may bearranged to deploy staples in a semi-circular or other desired shape.Although discussed with reference to intestinal tissue, devicesaccording to the present disclosure can be arranged to join and/or treatother tissues in other procedures.

Turning now to FIG. 2, an adhesive or support structure, in accordancewith an embodiment of the present disclosure, is generally designated as100. Structure 100 desirably has a shape corresponding to the arrays ofstaple receiving slots 36. Preferably, the structure 100 includes awasher-like or disk-like body portion 102 including a substantiallycentrally located aperture 104 formed therethrough. Structure 100 isdefined by an outer terminal edge 106, an inner terminal edge 108defining the size of aperture 104, an upper surface 110, and a bottomsurface 112.

In one embodiment, structure 100 is sized such that when structure 100is operatively associated with stapling device 10, as will be describedin greater detail below, outer terminal edge 106 extends radially beyondstaple retaining pockets 36 of staple cartridge assembly 22.Additionally, aperture 104 of structure 100 is sized to at least receiveshaft 28 of anvil assembly 30 therethrough. In another embodiment, thedistance between outer terminal edge 106 and inner terminal edge 108 issubstantially equal to a width of a tissue contact surface 24 (seeFIG. 1) of staple cartridge assembly 22.

It is contemplated that body portion 102 of structure 100 may befabricated from or include a surgical grade, biocompatible,non-absorbable (i.e., permanent) material; desirably a mesh impregnatedwith an adhesive, sealant and/or wound treatment material. For example,body portion 102 may be fabricated from “TEFLON”, which is a registeredtrademark owned by DuPont de Nemours & Co. It is further contemplatedthat body portion 102 may be fabricated from a biocompatible polymericfoam, felt, polytetrafluoroethylene (ePTFE), gelatin, fabric or thelike, or any other biocompatible material.

Non-absorbable materials used for body portion 102 include, and are notlimited to, those that are fabricated from such polymers aspolyethylene, polypropylene, nylon, polyethylene terephthalate,polytetrafluoroethylene, polyvinylidene fluoride, and the like. Furthernon-absorbable materials include and are not limited to stainless steel,titanium and the like.

In one embodiment, body portion 102 of structure 100 may be fabricatedfrom a bio-absorbable material which is desirably impregnated with anadhesive, sealant, and/or other wound treatment material (e.g., amedicament). Accordingly, a sealant component of structure 100 can beused to retard any bleeding which may occur from the tissue, an adhesivecomponent of structure 100 can be used to secure the approximated tissuetogether, and the bio-absorbability of structure 100 allows forstructure 100 to be absorbed into the body after a predetermined amountof time. For example, structure 100 may remain in place in the body forapproximately 2-3 weeks in order for the anastomosis to sufficientlyheal prior to structure 100 being absorbed into the body. In otherembodiments, the structure 100 has at least one portion that isabsorbable and at least one portion that is not absorbable.

Bio-absorbable materials used for body portion 102 of structure 100include, and are not limited to, those fabricated from homopolymers,copolymers or blends obtained from one or more monomers selected fromthe group consisting of glycolide, glycolic acid, lactide, lactic acid,p-dioxanone, α-caprolactone and trimethylene carbonate. Otherbio-absorbable materials include and are not limited to, for example,Polyglycolic Acid (PGA) and Polylactic Acid (PLA). In one embodiment,body portion 102 may be fabricated from bio-absorbable felt, ePTFE,gelatin or any other bio-absorbable materials.

It is contemplated that the adhesive is a biocompatible adhesiveincluding, but not limited to, adhesives which cure upon tissue contact,which cure upon exposure to ultraviolet (UV) light, which are two-partsystems which are kept isolated from one another and cure upon cominginto contact with one another, which are pressure sensitive, which areany combinations thereof, or any other known suitable adhesive. In oneembodiment, it is contemplated that an adhesive having a cure time offrom about 10 to 15 seconds may be used. In another embodiment, it iscontemplated that an adhesive having a cure time of about 30 seconds maybe used.

It is envisioned that body portion 102 of structure 100 may beimpregnated with a pre-cured adhesive or sealant. The pre-cured sealantor adhesive will react with the moisture and/or heat of the body tissueto thereby activate the sealing and/or adhesive properties of thesealant or adhesive. It is envisioned that the pre-cured sealant oradhesive may be a hydro-gel or the like.

It is envisioned that the wound treatment material “W” includes and isnot limited to one or a combination of adhesives, hemostats, sealants,coagulants, astringents, and medicaments. Other surgically biocompatiblewound treatment materials “W” which may be employed in or applied bysurgical instruments, including surgical staplers, include adhesiveswhose function is to attach or hold organs, tissues or structures;sealants to prevent fluid leakage; hemostats to halt or preventbleeding; coagulants, astringents (e.g., sulfates of aluminum) andmedicaments. Examples of adhesives which can be employed include proteinderived, aldehyde-based adhesive materials, for example, thecommercially available albumin/glutaraldehyde materials sold under thetrade designation BioGlue™ by Cryolife, Inc., and cyanoacrylate-basedmaterials sold under the trade designations Indermil™ and Derma Bond™ byTyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively.Examples of sealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc. Examples of hemostatmaterials, which can be employed, include fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats. Examples of commercially available hemostat materials arefibrinogen-thrombin combination materials sold under the tradedesignations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™ soldby Baxter International, Inc.

The wound treatment material may include a cross-linking material and/orreactive agent that reacts with the support structure, tissue or both.The resulting material acts as a seal or tissue joining material that isnon-absorbable. For example, the wound treatment material may be basedon biocompatible cross-linked polymers formed from water solubleprecursors having electrophilic and nucleophilic groups capable ofreacting and cross-linking in situ, including those disclosed in U.S.Pat. No. 6,566,406, the entire contents of which are incorporated hereinby reference.

The wound treatment material may be disposed on structure 100 orimpregnated into structure 100. Medicaments may include one or moremedically and/or surgically useful substances such as drugs, enzymes,growth factors, peptides, proteins, dyes, diagnostic agents orhemostasis agents, monoclonal antibodies, or any other pharmaceuticalused in the prevention of stenosis.

Wound treatment material “W” may include visco-elastic film formingmaterials, cross-linking reactive agents, and energy curable adhesives.It is envisioned that wound treatment material “W”, and in particular,adhesive may be cured with the application of water and/or glycerin(e.g., 1,2,3-pranatetriol, also known as glycerol and glycerine)thereto. In this manner, the water and/or glycerin cure the adhesive andhydrate the wound.

In one embodiment, it is contemplated that body portion 102 of structure100 may be impregnated with a first component of a two-part adhesive andthat the device deploys the second component of the two-part adhesive.For example, in a surgical stapler 10, the staples, which are retainedin staple receiving slots 36 of staple cartridge assembly 22, are coatedwith a second component (e.g., a reactant) of the two-part adhesive. Inthis manner, the first component of the adhesive is activated when thestaples penetrate and capture body portion 102 of structure 100 duringthe firing sequence of surgical stapling device 10, and the twocomponents of the adhesive contact one another.

As seen in FIG. 2, structure 100 may include a single layered bodyportion 102 including a homogeneous array of bio-absorbable ornon-absorbable materials or a heterogeneous array of bio-absorbableand/or non-absorbable materials. In certain embodiments, body portion102 is impregnated with a pressure sensitive adhesive which is activatedwhen adjacent layers of tissue are approximated, with the body portion102 disposed therebetween.

In an alternate embodiment, as seen in FIGS. 3 and 4, structure 100 mayinclude a layered body portion having at least two layers as indicatedby first layer, film or wafer 102 a and second layer, film or wafer 102b. In this embodiment, each layer 102 a, 102 b may include a homogeneousor heterogeneous array of bio-absorbable and/or non-absorbablematerials. It is envisioned that each layer 102 a, 102 b may beseparated from one another, as seen in FIG. 4, prior to the surgicalprocedure.

As will be described in greater detail below, first layer 102 a ofstructure 100 is placed against a surface of a first tissue to beanastomosed, in juxtaposition to a second tissue to be anastomosed, andsecond layer 102 b of structure 100 is placed against a surface of thesecond tissue to be anastomosed, in juxtaposition to the first tissue tobe anastomosed. In this manner, as the first and second tissues arebrought into contact with one another first and second layers 102 a, 102b of structure 100 are brought into contact with one another and allowedto mix and/or react. For example, first layer 102 a of structure 100includes a first component of a two-part adhesive or sealant whilesecond layer 102 b of structure 100 includes a second component of thetwo-part adhesive or sealant. Accordingly, in use, when first layer 102a and second layer 102 b come into contact with one another, the firstand second components of the two-part adhesive or sealant will also comeinto contact and mix to thereby form the adhesive or sealant.

First and second layers 102 a, 102 b may be fabricated as bio-absorbablefilm-like membranes which activate upon contact with one another and/orcontact with a fluid (e.g., water, saline, blood, an activating fluid,etc.). It is envisioned that a break-way or tear-away divider or barrier(not shown) may be positioned between first and second layers 102 a, 102b in order to prevent accidental and/or premature contact between firstand second layers 102 a, 102 b. It is further envisioned that each firstand second layer 102 a, 102 b may include a liner (not shown) removablydisposed on at least one of a top and bottom surface thereof. In any ofthese embodiments, prior to contact of first and second layers 102 a,102 b with one another, the divider and/or liners must be removed inorder for activation of the adhesive to occur.

It is further contemplated that the structure may be in the form of anabsorbable gel pack filled with adhesive. For example, the structure maybe a tubular ring, similar to annular adhesive structure 200 as will bedescribed in greater detail below.

In accordance with an embodiment of the present disclosure, as seen inFIG. 4, it is envisioned that each layer 102 a, 102 b of structure 100includes one portion of a hook and loop type fastener 120 (e.g.,Velcro™). For example, first layer 102 a includes a hook portion 120 aof hook and loop type fastener 120 disposed on a surface thereof, andsecond layer 102 b includes a loop portion 120 b of the hoop and looptype fastener 120 disposed on a surface thereof Accordingly, in use,first and second layers 102 a, 102 b are secured to one another via thehook and loop type fastener so as to provide more time for the twocomponents of the two-part adhesive or sealant to react with oneanother. Desirably, the hook and loop type fastener are fabricated frombio-absorbable materials.

As seen in FIGS. 5-7, each of first and second layers 102 a, 102 b ofstructure 100 includes an outer terminal edge 106 a, 106 b,respectively, and an inner terminal edge 108 a, 108 b respectively,defining a substantially centrally located aperture 104 a, 104 b, formedtherethrough. Apertures 104 a and 104 b are axially aligned with oneanother and are sized to permit positioning of shaft 28 of anvilassembly 30 therethrough.

First and second layers 102 a, 102 b are sized such that when structure100 is in an expanded condition, outer terminal edges 106 a, 106 b offirst and second layers 102 a, 102 b extend radially beyond staplereceiving slots 36 of staple cartridge assembly 22. First and secondlayers 102 a, 102 b may be fabricated from two laminated pieces ofpliable material, such as, for example, ePTFE.

Structure 100 further includes a ring, hoop or other circular member 130secured or disposed between first layer 102 a and second layer 102 b.Hoop 130 may be made from a resilient material, or a shape memory wire(e.g., NITINOL) wherein hoop 130 has a ring-like memorized shape.

It is envisioned that a layer of a reinforcing mesh or the like (notshown) may be disposed between first and second layers 102 a, 102 b, orincorporated within the first layer 102 a and/or second layer 102 b. Inthis manner, the reinforcing mesh may provide structure 100 withincreased strength and structural integrity to maintain the patency ofthe lumen between the anastomosed tissues.

The inner terminal edge 108 a, 108 b of structure 100 is operativelyconnected to shaft 28 of anvil assembly 30, and the structure 100 iscollapsed with hoop 130 biased against shaft 28 to thereby provide a lowprofile during insertion of anvil assembly 30 into the target surgicalsite. The structure 100 may be maintained collapsed against the shaft 28by a breakable sleeve or removable member. In use, the anvil assembly 30is connected to connection member 40 of tubular body portion 20 ofsurgical stapling device 10. Following insertion of anvil assembly 28,including structure 100, into the target surgical site and to the distalend of tubular body portion 20 of surgical stapling device 10, hoop 130is allowed to return to is memorized shape thereby expanding structure100 such that outer terminal edges 106 a, 106 b of first and secondlayers 102 a, 102 b extend radially beyond staple receiving slots 36 ofstaple cartridge assembly 22. The breakable sleeve may be broken uponintroduction of wound treatment material into the structure 100 or maybe connected to an actuator at a proximal end of the device.

Since first and/or second layers 102 a, 102 b of structure 100 may befabricated from a bio-absorbable material which is impregnated with awound treatment material, such as an adhesive, a sealant, and/or amedicament, in use, the sealant component would function to retard anybleeding which may occur from the tissue, the adhesive component wouldfunction to secure the approximated tissue together, and thebio-absorbability of structure 100 allows for at least a portion ofstructure 100 to be absorbed into the body after a predetermined amountof time. It is envisioned that hoop 130 may be fabricated from abio-absorbable material as well. In this manner, hoop 130 willultimately be absorbed into the body. For example, in such anembodiment, structure 100 may be constructed such that first and secondlayers 102 a, 102 b remain in place in the body for approximately 2-3weeks in order for the anastomosis to sufficiently heal while hoop 130remains in place in the body for some time after that in order to helpmaintain the patency of the lumen.

Turning now to FIG. 8, there is illustrated the use of surgical staplingdevice 10 and detachable anvil assembly 30 in an anastomosis procedureto effect joining of intestinal sections 66 and 68. The anastomosisprocedure is typically performed using minimally invasive surgicaltechniques including laparoscopic means and instrumentation. At thepoint in the procedure shown in FIG. 8, a diseased intestinal sectionhas been previously removed, anvil assembly 30 has been applied to theoperative site either through a surgical incision or trans-anally andpositioned within intestinal section 68, and tubular body portion 20 ofsurgical stapling device 10 has been inserted trans-anally intointestinal section 66. Intestinal sections 66 and 68 are also showntemporarily secured about their respective components (e.g., shaft 28 ofanvil assembly 30, and the distal end of tubular body portion 20) byconventional means such as a purse string suture “P” (see FIG. 9).

According to one method, as seen in FIG. 9, if desired or if thesurgical procedure requires, structure 100 may be placed onto shaft 28of anvil assembly 30 prior to the coupling of anvil assembly 30 to thedistal end of tubular body portion 20. Following positioning ofstructure 100 onto shaft 28 of anvil assembly 30, the surgeon maneuversanvil assembly 30 until the proximal end of shaft 28 is inserted intothe distal end of tubular body portion 20 of surgical stapling device10, wherein the mounting structure within the connection member 40 atthe distal end of tubular body portion 20 engages shaft 28 to effect themounting.

Thereafter, anvil assembly 30 and tubular body portion 20 areapproximated using rotatable grip member 18 of handle member 12 toapproximate intestinal sections 66, 68 and capture structure 100therebetween. Surgical stapling device 10 is then fired by manipulatingthe handle member 12 thereby stapling intestinal sections 66, 68 to oneanother and cutting the portion of tissue and structure 100 disposedradially inward of the knife, to complete the anastomosis. Structure 100may then release the adhesive impregnated therein to thereby adhereintestinal sections 66 and 68 to one another.

In the event that a structure 100, having a first and second layer 102a, 102 b each including one part of a two-part adhesive composition, isused, it is envisioned that first and second layers 102 a, 102 b aremaintained separated and/or isolated from one another untilapproximation and firing of surgical stapling device is to occur.Accordingly, in use, one of first and second layers 102 a, 102 b may beplaced on shaft 28 of anvil assembly 30, against the surface ofintestinal section 68, while the other of first and second layers 102 a,102 b is placed against the surface of intestinal section 66. It isenvisioned that pins (not shown) may extend distally from the distal endof tubular body portion 20 and penetrate through intestinal section 66.In this manner, the other of first and second layers 102 a, 102 b may bepinned onto the pins extending through intestinal section 66.

Alternatively, if a structure 100, having a first and second layer 102a, 102 b each including one part of a two-part adhesive composition, isused, it is envisioned that that each layer 102 a, 102 b may be providedwith a tear-away or removable liner for maintaining first and secondlayers 102 a, 102 b separated and/or isolated from one another.Accordingly, both first and second layers 102 a, 102 b may be placed onshaft 28 of anvil assembly 30.

If a structure 100, having a first and second layer 102 a, 102 b, eachincluding one part of a two-part adhesive composition, is used, theadhesive composition is activated upon first and second layers 102 a,102 b coming into contact with one another.

Turning now to FIGS. 10-15, in an embodiment of a support structure,support structure 100 includes at least one, preferably a pair ofdrapes, skirts or membranes 140, 142 (e.g., a first membrane 140 and asecond membrane 142) extending from outer terminal edge 106 of bodyportion 102. Desirably, membranes 140, 142 are fabricated from apolymeric or plastic film including, and not limited to, polyethyleneand the like. Each membrane 140, 142 includes a first or outer surface140 a, 142 a, respectively, and a second or inner surface 140 b, 142 b,respectively.

As seen in FIGS. 10 and 11, membranes 140, 142 have a first, undeployedcondition wherein membranes 140, 142 are rolled-up or others collapsedtowards body portion 102. Desirably, membranes 140, 142 are rolled underin a direction toward the first or outer surfaces 140 a, 142 a thereof,as indicated by arrows “A” of FIG. 11. As seen in FIGS. 12 and 13,membranes 140, 142 have a second, deployed condition wherein membranes140, 142 are unrolled or unfurled to extend in a substantially parallelorientation with respect to the central “X” axis. As will be describedin greater detail below, first membrane 140 is unrolled in a firstdirection, preferably in a distal direction (e.g., in a directionextending away from upper surface 110 of body portion 102), and secondmembrane 142 is unrolled in a second direction, preferably in a proximaldirection (e.g., in a direction extending away from lower surface 112 ofbody portion 102).

As seen in FIGS. 10 and 11, support structure 100 desirably includes oneor more rip-cords or tethers 144, 146 rolled-up into membranes 140, 142.Rip-cords 144, 146 include free ends 144 a, 146 a which extend frommembranes 140, 142 when membranes 140, 142 are in the rolled-upcondition. In this manner, as will be described in greater detail below,as rip-cords 144, 146 are pulled, desirably in a distal direction and aproximal direction, membranes 140, 142 are un-rolled or un-furledaccordingly.

In one embodiment, it is envisioned that body portion 102 of supportstructure 100 is formed of a foam material overmolded onto a relativelythin flexible material or film integral with membranes or sleeves 140,142. Desirably, when un-rolled or un-furled, each membrane 140, 142extends approximately 2.0 cm from body portion 102. In other words, whenun-rolled or un-furled, first membrane 140 extends from body portion 102by approximately 2.0 cm from upper surface 110 of body portion 102, andsecond membrane 142 extends from body portion 102 approximately 2.0 cmfrom lower surface 112 of body portion 102.

Turning now to FIGS. 14 and 15, there is illustrated the use of surgicalstapling device 10 and support structure 100 in an anastomosis procedureto effect joining of intestinal sections 66 and 68. The anastomosisprocedure is typically performed using minimally invasive surgicaltechniques including laparoscopic means and instrumentation. At thepoint in the procedure shown in FIGS. 14 and 15, a diseased intestinalsection has been previously removed, anvil assembly 30 has beenintroduced to the operative site either through a surgical incision ortrans-anally and positioned within intestinal section 68, and tubularbody portion 20 of surgical stapling device 10 has been insertedtrans-anally into intestinal section 66. Intestinal sections 66 and 68are also shown temporarily secured about their respective components(e.g., shaft 28 of anvil assembly 30, and the distal end of tubular bodyportion 20) by conventional means such as a purse string suture “P”.

Support structure 100 is then placed onto shaft 28 of anvil assembly 30prior to the coupling of anvil assembly 30 to the distal end of tubularbody portion 20. In particular, shaft 28 of anvil assembly 30 isinserted into aperture 104 of body portion 102. Following positioning ofstructure 100 onto shaft 28 of anvil assembly 30, the surgeon maneuversanvil assembly 30 until the proximal end of shaft 28 is inserted intothe connection member 40 at the distal end of tubular body portion 20 ofsurgical stapling device 10, wherein the mounting structure (not shown)within the connection member 40 engages shaft 28 to effect the mounting.

Thereafter, as seen in FIG. 15, anvil assembly 30 and tubular bodyportion 20 are approximated to approximate intestinal sections 66, 68and capture body portion 102 of structure 100 therebetween. With bodyportion 102 captured between intestinal sections 66, 68, as seen in FIG.15, membranes 140, 142 are deployed (i.e., un-rolled or un-furled) asdescribed above. In particular, first membrane 140 is un-rolled orun-furled in a distal direction, as indicated by arrow “B”, so as toover-lie intestinal section 68, and second membrane 142 is un-rolled orun-furled in a proximal direction, as indicated by arrow “C”, so as toover-lie intestinal section 66. Desirably, first and second membranes140, 142 are un-rolled or un-furled by pulling on rip-cords 144, 146 ina distal or proximal direction, as necessary.

Membranes 140, 142 extend a predetermined distance over intestinalsections 66 and 68 (e.g., approximately 2 cm). When un-rolled orun-furled, membranes 140, 142 desirably adhere to the surface ofintestinal sections 66, 68. The membranes may comprise apressure-sensitive adhesive, or other adhesive material, incorporatedwith the membranes or coated thereon. Membranes 140 and 142 function toinhibit leakage from the anastomosis site and/or function to strengthenor reinforce intestinal sections 66, 68. With membranes 140, 142deployed, as seen in FIG. 15, surgical stapling device 10 may be firedthereby stapling intestinal sections 66, 68 to one another and cuttingthe portion of tissue and structure 100 disposed radially inward of theknife, to complete the anastomosis.

Turning now to FIGS. 16-21, structure 100 includes at least one,preferably a pair of membranes 150, 152 (e.g., a first membrane 150 anda second membrane 152) extending from outer edge 106 of body portion102. Each membrane 150 and 152 includes two layers, an inner layer 150a, 152 a, respectively, and an outer layer 150 b, 152 b, respectively.Desirably, the materials selected for the construction of membranes 150,152 swell at different rates when in the presence of moisture or fluid.In this manner, membranes 150, 152 will tend to bend or curl about thelayer having the relatively slower rate of fluid swelling or fluidabsorption. In this manner, support structure 100 has a first undeployedcondition in which membranes 150, 152 extend substantially radiallyoutward from body portion 102, and a second deployed condition in whichmembranes 150, 152 are substantially aligned with the central “X” axisof body portion 102.

In accordance with one embodiment, it is envisioned that inner layer 150a, 152 a of membranes 150, 152 are constructed from a material that doesnot substantially absorb moisture or non-expanding (i.e., static)material, such as, for example, a bio-absorbable mesh fabricated frompolyglycolic acid, sold under the tradename Dexon™, available from TycoHealthcare Group LP, Norwalk, Conn. It is also envisioned that outerlayer 150 b, 152 b of membranes 150, 152 are constructed from a moistureabsorbing or expanding (i.e., dynamic) material, such as, for example,hydrogel and the like.

Desirably, each membrane 150 and 152 includes a hydrogel outer layer 150b, 152 b laminated to a bio-absorbable mesh inner layer 150 a, 152 a.Furthermore, support structure 100 includes a foam body portion 102laminated over the layered membrane 150, 152 materials. While eachmembrane 150, 152 desirably includes a pair of layers, it is envisionedand within the scope of the present disclosure for membranes 150, 152 toinclude any number of layers.

Accordingly, with reference to FIG. 18, the difference in materialproperties between inner layers 150 a, 152 a and outer layers 150 b, 152b of membranes 150, 152 cause membranes 150, 152 to curl or bend fromthe undeployed condition, wherein membranes 150, 152 extend in asubstantially radial direction, to a deployed condition, whereinmembranes 150, 152 extend in a direction substantially parallel to thecentral “X” axis (as shown in phantom in FIG. 18).

Turning now to FIGS. 19 and 20, there is illustrated the use of surgicalstapling device 10 and support structure 100 including membranes 150,152 in an anastomosis procedure to effect joining of intestinal sections66 and 68. At the point in the procedure shown in FIG. 19, anvilassembly 30 and tubular body portion 20 are shown approximated to oneanother to capture body portion 102 of annular support structure 100between intestinal sections 66 and 68, wherein intestinal section 66 and68 were previously secured about their respective components (e.g.,shaft 28 of anvil assembly 30, and the distal end of tubular bodyportion 20) by conventional means such as a purse string suture “P”,annular support structure 100 was positioned between intestinal sections66 and 68, and anvil assembly 30 was coupled to the distal end oftubular body portion 20.

With body portion 102 of support structure 100 captured betweenintestinal sections 66, 68, as seen in FIGS. 12 and 13, membranes 150,152 begin to deploy (i.e., curl or bend from the substantially radiallyextended orientation to the orientation substantially parallel with thecentral “X” axis) as described above. In particular, as outer layers 150b, 152 b of first and second membranes 150, 152 absorb fluid and swell(i.e., expand), first and second membranes 150, 152 curl or bend to theside of membrane 150, 152 which swells or expands at a rate slower,i.e., toward inner layers 150 a, 152 a. As membranes 150, 152 aredeployed, as indicated by arrow “B”, first membrane 150 over-liesintestinal section 68, and second membrane 152 over-lies intestinalsection 66, as indicated by arrow “C”.

Desirably, membranes 150, 152 extend a predetermined distance overintestinal sections 66 and 68 (e.g., approximately 2 cm). Membranes 150,152 are arranged so that they will adhere to the surface of intestinalsections 66, 68. Membranes 150, 152 function to inhibit leakage from theanastomosis site and/or function to strengthen or reinforce intestinalsections 66, 68. With membranes 150, 152 deployed, as seen in FIG. 20,surgical stapling device 10 may be fired thereby stapling intestinalsections 66, 68 to one another and cutting the portion of tissue andstructure 100 disposed radially inward of the knife, to complete theanastomosis.

In a further embodiment, as seen in FIG. 21, structure 100 includes aseries of ribs 156, 158 provided on and/or in each membrane 150, 152,respectively. Desirably, ribs 156, 158 are spaced radially around theperimeter or circumference of membranes 150, 152. Ribs 156, 158 aresubstantially axially oriented.

Ribs 156, 158 are fabricated from a shape memory material, alloy or thelike, preferably, NITINOL™ and the like. Alternatively, the ribs may befabricated from a polymeric material. It is further envisioned that ribs156, 158 may be fabricated from a bio-absorbable or non-absorbablematerial.

Ribs 156, 158 have a memorized shape which is oriented substantiallyparallel to the central “X” axis of support structure 100. In thismanner, support structure 100 has a first or un-deployed condition inwhich ribs 156, 158 are in a biased rolled-up or otherwise collapsedcondition and membranes 150, 152 are also rolled-up or otherwisecollapsed, and a second or deployed condition in which ribs 156, 158 arein their memorized shape or unbiased condition and membranes 150, 152are extended.

In use, with support structure in an un-deployed condition, supportstructure 100 is positioned on shaft 28 of anvil assembly 30. Withsupport structure 100 so positioned, support structure 100 is deployedwhen ribs 156, 158 return to their memorized conditions. In particular,the return of ribs 156, 158 to their memorized conditions extendsmembranes 150, 152 over intestinal sections 66 and 68 and/or in adirection substantially parallel to the central “X” axis.

Turning now to FIGS. 22-30, a support structure assembly, in accordancewith an embodiment of the present disclosure, is generally designated as180 and is operatively supported on shaft 28 of anvil assembly 30. Asmentioned above, anvil assembly 30 includes an anvil member 26 and ashaft 28, extending from anvil member 26 and being operativelyconnectable with a distal end portion of stapling device 10.

Anvil assembly 30 includes a support structure assembly 180 operativelydisposed on shaft 28 thereof. Support structure assembly 180 includessleeve 160 operatively disposed on shaft 28 of anvil assembly 30. Sleeve160 includes a proximal portion 1610 a having a diameter slightly largerthan the diameter of shaft 28, and a distal portion 160 b having adiameter larger than the diameter of proximal portion 160 a and defininga chamber 162 between shaft 28 and distal portion 160 b.

Sleeve 160 is movable along the length of shaft 28 from a first positionin which sleeve 160 is in close proximity to anvil member 30 (see FIGS.22 and 23) and a second position in which sleeve 160 is spaced adistance from anvil member 28 (see FIGS. 24 and 25). Desirably, a camsurface 164 is formed in an inner surface 161 a of proximal portion 160a of sleeve 160. Additionally, a cam follower 166 is provided on shaft28 and operatively engages cam surface 164 of sleeve 160. Desirably,during use, anvil 26 is drawn closer to the tubular body portion 20, asdiscussed above. The cam follower 166 rides in cam surface 164 so thatsleeve 160 is axially displaced with respect to shaft 28 (e.g., betweenthe first and second positions). Preferably, as shaft 28 is drawnproximally, the cam follower 166 and cam surface 164 interact so thatsleeve 160 moves proximally move quickly than shaft 28.

Support structure assembly 180 further includes a support structure 170operatively supported on shaft 28. Support structure 170 has a collapsedor first condition, as seen in FIG. 23, wherein support structure 170 isretained within chamber 162 of sleeve 160, and an expanded or secondcondition, as seen in FIGS. 24 and 25, wherein support structure 170 isfree from chamber 162 of sleeve 160 and extends radially outward fromshaft 28.

As seen in FIGS. 23-28, and in particular FIGS. 26-28, support structure170 preferably includes a central hub 172, a plurality of spokes 174extending from hub 172, and a disc 176 operatively connected to thedistal end of spokes 174. Desirably, support structure 170 includes aring 178 operatively connected to the distal end of each spoke 174. Ring178 and spokes are desirably resilient and collapsible and provides disc176 with an increased degree of structural integrity. Preferably, spokes174 and ring 178 are made from a wire of shape memory material (e.g.,NITINOL and the like), wherein spokes 174 and/or ring 178 have amemorized shape with the spokes radially oriented with respect to hub172 and ring 178 having a hoop-like shape.

As best seen in FIGS. 27 and 28, disc 176 preferably includes a firstdisc 176 a disposed on a first side of ring 178, and a second disc 176 bdisposed on a second side of ring 178. Preferably, discs 176 a, 176 bhave a width sufficient to extend across staple receiving slots 36. Inthis manner, as will be discussed in greater detail below, when surgicalstapling device 10 is fired, staples 38 (see FIGS. 29 and 30) are driventhrough discs 176 a, 176 b.

It is contemplated that first and second discs 176 a, 176 b may befabricated from any of the materials disclosed above. In an embodiment,first and second discs 176 a, 176 b are impregnated with a woundtreatment material.

Turning now to FIGS. 29 and 30, a method of using support structureassembly 180 is shown and described. The anastomosis procedure istypically performed using minimally invasive surgical techniquesincluding laparoscopic means and instrumentation. At the point in theprocedure shown in FIG. 29, a diseased intestinal section has beenpreviously removed, anvil assembly 30 has been applied to the operativesite, and distal end 22 of body portion 20 (i.e., the tubular bodyportion) of surgical stapling apparatus 10 has been inserted into asecond intestinal section 68.

According to the present method, following positioning of anvil assembly30 and the distal end of tubular body portion 20 within intestinalsections 66 and 68, respectively, the surgeon maneuvers anvil assembly30 until a proximal end of shaft 28 is inserted into a connection member40 provided in the distal end of tubular body portion 20 of surgicalstapling device 10. Connection member 40 desirably connects the proximalend of shaft 28 and proximal portion 160 a of sleeve 160 in order toeffect the mounting of anvil assembly 30 to tubular body portion 20.Connection member 40 may include a rod 41 disposed within the tubularbody portion 20 which has a detent structure for engaging shaft 28.

Thereafter, anvil assembly 30 and tubular body portion 20 areapproximated to approximate intestinal sections 66, 68 and move sleeve160 from the first position to the second position in order to deploysupport structure 170. In particular, during approximation of anvilassembly 30 and tubular body portion 20, as seen in FIG. 29, sleeve 160is moved in a proximal direction, from the first position to the secondposition (as indicated by arrow “A”), relative to shaft 28, as discussedabove.

As sleeve 160 is moved in a proximal direction relative to shaft 28,support structure 170 is exposed from a distal end of sleeve 160. Asseen in FIG. 30, once sleeve 160 has moved in the proximal directionrelative to shaft 28 by an amount sufficient for the distal end thereofto completely clear support structure 170 or until proximal portion 160a of sleeve 160 abuts against, e.g., bottoms out against, an enlargedhead 28 a provided at a proximal end of shaft 28, support structure 170is deployed (i.e., spokes 174 and ring 178 are returned to theirmemorized or pre-biased conditions).

As seen in FIG. 30, with support structure 170 deployed, disc 176 isexpanded between first and second intestinal sections 66, 68 andsubstantially overlies and/or comes into registration with staplereceiving slots 36 of staple cartridge assembly 22. With supportstructure 170 deployed between first and second intestinal sections 66,68, anvil assembly 30 is further approximated toward tubular bodyportion 20 to thereby clamp disc 176 between first and second intestinalsections 66, 68. With anvil assembly 30 fully approximated toward bodyportion 20, surgical stapling device 10 is fired thereby stapling disc176 between intestinal sections 66, 68. Additionally, concomitantlytherewith, the knife (not shown) is actuated to sever the portion ofintestinal sections 66, 68 and the portion of spokes 174 locatedradially inward from the knife, thereby completing the anastomosis.

From the foregoing, it will be appreciated that disc 176 of supportstructure 170 functions to strengthen the anastomosis and reduce theoccurrence of bleeding, leaking and stricture. It is also to beappreciated that the annular adhesive structures of the presentdisclosure may be utilized in a number of other applications and is notlimited solely to bowel or bronchus anastomosis.

Turning now to FIGS. 31-37, a support structure 200, in accordance withan alternate embodiment of the present disclosure, is shown supported onstem 1028 of anvil member 1026 of annular surgical stapling device 1000.Surgical stapling device 1000 is substantially similar to surgicalstapling device 10 and will only be discussed in detail to the extentnecessary to identify differences in construction and operation.

As seen in FIGS. 32-34, support structure 200 includes an outer circularrim, tube or doughnut 202, a plurality of spokes 204 extending radiallyinward from circular tube 202, and a central hub 206 operatively joiningspokes 204. Circular tube 202 is generally toroidal in shape when in anexpanded condition. Central hub 206 defines a lumen 208 therethrough,having a central longitudinal “X” axis, for receipt of stem 1028 ofanvil member 1026.

As seen in FIG. 34, circular tube 202 of support structure 200 defines acavity 202 a therein, and spokes 204 act as conduits for transmittingfluid (e.g., wound treatment material “W”) to cavity 202 a of circulartube 202. Central hub 206 includes a plurality of apertures 206 a formedtherein and which are in fluid communication with spokes 204. Apertures206 a of central hub 206 are in fluid communication with ports 1028 a(see FIG. 32) formed in stem 1028 of anvil member 1026. Ports 1028 a arein fluid communication with a conduit or passage 1028 b extendingaxially through stem 1028 of anvil member 1026. Conduit 1028 b isfluidly connected to a source of fluid (not shown), when anvil member1026 is coupled to connection means 1040 (see FIG. 31), in order todeliver a fluid (e.g., wound treatment material “W”) to cavity 202 a ofcircular tube 202.

Support structure 200 has a first unexpanded or deflated condition inwhich cavity 202 a of circular tube 202 is unfilled and circular tube202 and spokes 204 are wrapped around, collapsed onto, or otherwise inclose proximity to stem 1028 of anvil member 1026. Support structure 200has an expanded condition in which cavity 202 a of circular tube 202 isfilled with wound treatment material “W”.

As seen in FIGS. 32-34, circular tube 202 is provided with a pluralityof perforations 210 formed therein. Preferably, perforations 210 areformed along an upper or distal surface 203 of circular tube 202.Additionally, perforations 210 extend at least partially around, andpreferably completely around, the circumference or perimeter of circulartube 202. In this manner, as will be described in greater detail below,wound treatment material “W” is dispensed from perforations 210 whencircular tube 202 is expanded or inflated with wound treatment material“W”.

As seen in FIG. 34, spokes 204 are angled by a degree “Θ” with respectto the longitudinal “X” axis of hub 206. Desirably, spokes 204 areangled in a distal direction when support structure 200 is in aninflated condition. In one embodiment, when support structure 200 is inthe inflated condition, spokes 204 are angled by a degree “Θ” andsufficient for circular tube 202 to be in close proximity to a tissuecontacting surface of anvil member 1026. Preferably, as will bedescribed in greater detail below, when support structure 200 is in theinflated condition, circular tube 202 will substantially contact thetissue “T” purse string sutured to anvil member 1026.

While support structure 200 has been shown and described as includinghub 206, it is envisioned and within the scope of the present disclosurethat spokes 204 may be directly connected to stem 1028 and, moreparticularly, fluidly connected to ports 1028 a of stem 1028.

It is envisioned that the wound treatment material “W” can include oneor a combination of wound treatment materials, such as adhesives,hemostats, sealants, medicaments and the like as described above.

Turning now to FIGS. 35-37, a method of using support structure 200 fordistributing and/or dispensing wound treatment material is shown anddescribed. The anastomosis procedure is typically performed usingminimally invasive surgical techniques including laparoscopic means andinstrumentation. At the point in the procedure shown in FIG. 35, adiseased intestinal section has been previously removed, anvil assembly1030 has been applied to the operative site, and distal end 1022 of bodyportion 1020 (i.e., the tubular body portion) of surgical staplingapparatus 1000 has been inserted into a second intestinal section “T2”.

Following positioning of anvil assembly 1030 and distal end 1022 of bodyportion 1020 within intestinal sections “T1 and T2”, the surgeonmaneuvers anvil assembly 1030 until the proximal end of stem 1028 isinserted into the distal end of connection means 1040 to effect mountingof anvil assembly 1030 to connection means 1040. With anvil assembly1030 mounted to connection means 1040, as seen in FIG. 35, supportstructure 200 is expanded to the inflated condition by injecting woundtreatment material “W”, through conduit 1028 b of stem 1028, throughspokes 204, and into cavity 202 a of circular tube 202. The proximal endof the tubular body portion desirably includes a button, plunger orother actuator for dispensing wound treatment material to supportstructure 200.

As the pressure of wound treatment material “W” within support structure200 increases, as seen in FIG. 36, circular tube 202 comes into contactwith or substantially approaches first intestinal section “T1” and woundtreatment material “W” is dispensed from apertures 210. As woundtreatment material “W” is dispensed from support structure 200, woundtreatment material “W” is deposited on first intestinal section “T1”.Preferably, wound treatment material “W” is deposited completely aroundfirst intestinal section “T1”.

While it is shown and described that support structure 200 is configuredto deposit wound treatment material “W” onto first intestinal section“T1”, it is envisioned and within the scope of the present disclosurefor support structure 200 to be configured to dispense wound treatmentmaterial “W” onto second intestinal section “T2”.

As seen in FIGS. 36 and 37, following deposition of wound treatmentmaterial “W” onto first intestinal section “T1”, support structure, andin particular circular tube 202 is deflated by withdrawing woundtreatment material “W” through conduit 28 b and spokes 204. Supportstructure 200 may include a suture attached to circular tube 202, whichextends through tubular body portion 1022 to the proximal end ofapparatus 1000, so that the user in pulling on the suture can collapseand/or remove the structure 200. Alternatively, the support structure200 may include an elastic, expandable material. With wound treatmentmaterial “W” deposited on first intestinal section “T1” and with supportstructure 200 deflated, anvil member 1026 and tubular body portion 1022are approximated to approximate first intestinal section “T1” and secondintestinal section “T2”. The rotatable grip member 1018 is used toapproximate the anvil member 1026 and tubular body portion 1022. Whenfirst intestinal section “T1” is in contact with second intestinalsection “T2”, wound treatment material “W” is sandwiched therebetween.

Surgical stapling apparatus 1000 is then fired by operating handlemember 1012, thereby stapling first intestinal section “T1” to secondintestinal section “T2”. Upon firing of surgical stapling apparatus1000, the staples are expelled from distal end 1022 of body portion 1020by the staple pusher member (not shown) and driven through first andsecond intestinal sections “T1 and T2”. Additionally, an annular knife,disposed radially inward of the staple pockets 1024, severs theintestinal tissue radially inwardly of the staple pockets 1024, tothereby complete the anastomosis.

In an alternate method, it is envisioned that the surgical anastomosisprocedure may be accomplished without staples. Accordingly, followingdeposition of wound treatment material “W” onto first intestinal section“T1” and/or second intestinal second “T2”, anvil member 1026 isapproximated toward distal end 1022 of body portion 1020 until firstintestinal second “T1” contacts second intestinal section “T2” therebysqueezing wound treatment material “W” therebetween. Depending on theparticular wound treatment material “W” (e.g., adhesive) used, anvilmember 1026 is maintained approximated against distal end 1022 of bodyportion 1020 for a time sufficient for wound treatment material “W” tocure and begin to adhere first intestinal section “T1” and secondintestinal section “T2” with one another. The choice of wound treatmentmaterial “W” (e.g., adhesive) will determine the time required tomaintain anvil member 1026 approximated against distal end 1022 of bodyportion 1020.

From the foregoing, it will be appreciated that support structure 200functions to strengthen the anastomosis and reduce the occurrence ofbleeding, leaking and stricture. It is also to be appreciated that thewound treatment material applying structure of the present disclosuremay be utilized in a number of other applications and is not limitedsolely to bowel or bronchus anastomosis.

In one embodiment, it is envisioned that apertures 210 may be areaswhere tube 202 has been weakened. In this manner, as the pressure withintube 202 increases during inflation, these weakened areas will open upand become apertures 210 and allow for wound treatment material “W” tobe dispensed therefrom.

As seen in FIGS. 38 and 39, support structure 200 may be fabricated froma polymeric material and may form a circular or “wagon wheel” shapedstructure when in the expanded condition. Desirably, spokes 204 extendradially from central hub 206. In the present embodiment, circular tube202 of support structure 200 does not include apertures 210 formedtherein.

In use, structure 200 is inflated at a location between the two layersof tissue to be anastomosed. In this manner, as will be described ingreater detail below, when surgical stapling device 1000 is fired, thestaples penetrate and/or puncture circular body 202, thereby releasingwound treatment material “W” between the two layers of tissue, and actsto capture circular tube 202 between the two layers of tissue. Thefiring of surgical stapling device 1000 then drives the knife to severspokes 204 from the captured circular tube 202, and thereby leavecircular tube 202 in position. The circular tube 202, as well as otherportions of structure 200, may be formed from bio-absorbable materials.In an alternate method, when the staples puncture circular body 202, theelasticity of support structure 200 causes circular body 202 and spokes204 to collapse and/or retract back onto hub 206 of shaft 1028 of anvilassembly 1030, in the manner of a popped balloon.

Circular tube 202 may be constructed from any of the materials listedabove for the fabrication of structure 100. Circular tube 202 may bereinforced with a mesh or other material in order to thereby provideadditional structural integrity and strength. In addition, when thestaples penetrate circular tube 202 the staples may capture the mesh andthereby further help to maintain the patency of the lumen between thetwo layers of anastomosed tissue.

It is contemplated that structure 200 may be used with a two-partadhesive composition by dividing cavity 202 a into two separate chamberswith each chamber receiving a respective component of the two-partadhesive composition. Alternatively, it is envisioned that a pair ofstructures 200 may be mounted to shaft 1028 of anvil assembly 1030, witheach structure 200 being fluidly connected to a respective component ofthe two-part adhesive composition.

In the alternative, the structure 200 in FIGS. 38 and 39 may include acollapsible foam that is attached to shaft 1028 and maintained in acollapsed condition. A wound treatment material is delivered to the foamstructure through apertures 1028 a, thereby expanding the foam.Desirably, the wound treatment material includes a cross-linkingmaterial or is reactive with the foam to form an adhesive or sealantmaterial.

Turning now to FIGS. 40 and 41, a support structure, in accordance withan alternate embodiment of the present disclosure, is generallydesignated as 300. Support structure 300 is generally an annular balloon302 secured to stem 1028 of anvil member 1026 at a first end 302 a andat a second end 302 b. Desirably, first end 302 a of annular balloon 302is secured or attached (e.g., adhered) to stem 1028 at a location distalof port 1028 a, and second end 302 b of annular balloon 302 is securedor attached (e.g., adhered) to stem 1028 at a location proximal of port1028 a. In this manner, as wound treatment material “W” is transmittedthrough passage 1028 b of stem 1028, wound treatment material “W” exitsthrough ports 1028 a and fills cavity 304 of annular balloon 302.

As seen in FIG. 41, annular balloon 302 includes a plurality ofapertures or perforations 306 formed along a perimetral edge 310thereof. Accordingly, as wound treatment material “W” fills cavity 304and the pressure in cavity 304 builds, wound treatment material “W”begins to dispense from perforations 306. Desirably and in accordancewith the present disclosure, annular balloon 302 is configured anddimensioned such that perimetral edge 310 and perforations 306 aredisposed between adjacent layers of tissue “T1, T2” (shown in phantom inFIG. 41) which are to be secured to one another.

With reference to FIGS. 42-44, a support structure according to yetanother embodiment of the present disclosure is generally designated as400. Structure 400 may be fabricated from any of the materials listedabove for the fabrication of structure 100. Structure 400 may have aplanar disk-like first, deflated or unexpanded condition, as seen inFIGS. 42 and 43, and a toroidal second, inflated or expanded condition,as seen in FIG. 44.

Structure 400 includes a tubular body portion 402 including asubstantially centrally located aperture 404 formed therethrough.Structure 400 is defined by an outer terminal edge 406, and an innerterminal edge 408 defining the size of aperture 404. Structure 400 issized such that when structure 400 is operatively associated withstapling device 1000, outer terminal edge 406 extends beyond stapleretaining pockets 1036 of staple cartridge assembly 1022. Additionally,aperture 404 of structure 400 is sized to at least receive shaft 1028 ofanvil assembly 1030 therethrough.

Body portion 402 of structure 400 defines an internal cavity or chamber(not shown) for receiving a wound treatment material, including, and notlimited to, a sealant, adhesive, medicament or the like, therein. A port420 may be provided on body portion 402 through which fluid may beinjected into the cavity thereof

As seen in FIG. 43, a fluid delivery device, in the form of a syringe“S”, may be used to inject and/or deliver fluid, in the form of asealant, adhesive, medicament or the like, to the cavity of body portion402. As seen in FIG. 44, when structure 400 is inflated with a fluid,structure 400 may have a toroidal shape. While structure 400 is shown inFIG. 44 as having a toroidal shape, when in the inflated condition, itis envisioned and within the scope of the present disclosure thestructure 400 may have a washer-like, cylindrical, spherical or othershape, when in the inflated condition.

Similar to structure 200, in use, with adhesive structure 400 in theinflated condition and positioned on shaft 1028 of anvil assembly 1030,tubular body portion 1020 and anvil assembly 1030 are approximated toapproximate intestinal sections 66, 68 and capture annular adhesivestructure 400 therebetween. Surgical stapling device 1000 is then firedthereby stapling intestinal sections 66, 68 to one another. Upon firingof surgical stapling device 1000, staples are expelled from staplecartridge assembly 1022 and driven through intestinal sections 66, 68and body portion 402 thereby puncturing body portion 402 and expellingthe fluid therefrom.

Turning now to FIGS. 45 and 46, an applicator 500, in accordance with anembodiment of the present disclosure, is shown supported on stem 1028 ofanvil assembly 1030 of surgical stapling device 1000.

As seen in FIGS. 45 and 46, applicator 500 includes an anvil member 1026with a tubular sleeve 502 configured and adapted to selectively engageconnection member 1040 of surgical stapling device 1000. The connectionmember 1040 is attached to a shaft 1020 a of the tubular body portion1020. The tubular body portion 1020 also has a recess 1020 b formedinwardly of the rows of staples. The remainder of the surgical staplingdevice 1000 is substantially as discussed above.

A proximal end 502 a of sleeve 502 is configured to connect withconnection member 1040, using a detent, ¼ turn lock, threadedconnection, latch, or bayonet-type connection. For example, connectionmember 1040 of surgical stapling instrument 1000 is inserted into theproximal end of sleeve 502 and rotated in order to lock applicator 500and anvil assembly 1030 onto connection member 1040 of surgical staplingdevice 1000. In particular, sleeve 502 may include an L-shaped slot 504configured and dimensioned to slidably receive a nub 1040 a ofconnection member 1040.

Applicator 500 includes a manifold 506 disposed between the anvil member1026 and body portion 1020. The manifold 506 is supported on a distalend of sleeve 502. Manifold 506 may be in the form of a disc having acenter which is substantially aligned with a longitudinal axis of stem1028 of anvil assembly 1030. It is contemplated that manifold 506 has anouter diameter which is less than the outer diameter of anvil 1026.

Manifold 506 includes a plurality of radially oriented channels 506 aformed therein. Each channel 506 a is in fluid communication with theinterior of sleeve 502. Channels 506 a of manifold 506 may be in fluidcommunication with ports 1028 a (see FIG. 32) formed in stem 1028 ofanvil assembly 1030, which ports 1028 a may be in fluid communicationwith sleeve 502. The manifold, which is desirably formed from asubstantially rigid material, is dimensioned to terminate inwardly ofthe rows of staples. In FIG. 45, the channels 506 a are open at thelateral sides of the manifold 506. In other embodiments, the channels506 a may be open on the distal-most or proximal-most surface of themanifold.

The interior of the tubular sleeve 502 forms a chamber 502 b for anampoule of the applicator 500. Ampoule 510 is configured and adapted toretain a quantity of wound treatment material therein. For example, itis envisioned that the wound treatment material can include one or acombination of wound treatment materials, such as adhesives, hemostats,sealants, medicaments and the like as described above. The tubularsleeve 502 may include an aperture or window 502 c through which theampoule 510 may be viewed. The state of the ampoule 510 as full orpartially or completely dispensed may be viewed through aperture orwindow 502 c. The ampoule 510 desirably comprises a plastic cartridgethat is arranged to direct the wound treatment material in a distaldirection, toward the manifold 506, and away from the aperture or window502 c.

In is envisioned and contemplated that ampoule 510 is actuatable todispense the wound treatment material contained therein into sleeve 502.In particular, upon actuation of ampoule 510, the wound treatmentmaterial contained therein is dispensed into sleeve 502 and further oninto channels 506 a of manifold 506. In this manner, wound treatmentmaterial may be dispensed into the target surgical site.

Applicator 500 may further include a seal 512 interposed between ampoule510 and sleeve 502 in order to ensure that the wound treatment materialis efficiently directed into channels 506 a of manifold 506.

It is envisioned and contemplated that a driver (not shown) may advancea plunger (not shown) through ampoule 510 in order to force the woundtreatment material out of ampoule 510 and through channels 506 a ofmanifold 506. Alternatively, an interior threaded shaft may be used toapproximate sleeve 502 with respect to shaft 1020 a, thereby compressingampoule 510 to force wound treatment material out of ampoule 510.

Reference may be made to U.S. application Ser. No. 11/250,277, filedOct. 14, 2005, the entire contents of which is hereby incorporatedherein by reference, for a more detailed description of the ampouleconfigured for retention of a wound treatment material therein.

A method of using surgical stapling device 1000, including applicator500 is now described. Following positioning of anvil assembly 1030 anddistal end 1022 of body portion 1020 within intestinal sections “T1” and“T2”, and securing the anvil assembly 1030 and distal end 1022 to theintestinal sections “T1” and “T2”, the surgeon maneuvers anvil assembly1030 until the proximal end of sleeve 502 is slid over connection member1040 and locks anvil assembly 1030 onto connection member 1040 ofsurgical stapling device 1000.

With anvil assembly 1030 mounted to connection means 1040, anvil member1026 and tubular body portion 1022 are approximated to approximate firstintestinal section “T1” and second intestinal section “T2”. Therotatable grip member 1018 is used to approximate the anvil member 1026and tubular body portion 1022. It is contemplated that first intestinalsection “T1” and second intestinal section “T2” are approximated suchthat a radially outer edge of manifold 506 is located in close proximityto at least one of first intestinal section “T1,” second intestinalsection “T2”, and/or the interface therebetween.

When first intestinal section “T1” is in close proximity to secondintestinal section “T2”, applicator 500 may be actuated to dispense thewound treatment material onto first intestinal section “T1” and/orsecond intestinal section “T2”. For example, a button, plunger or otheractuator may be provided on the handle assembly of the device 100 forforcing the wound treatment material out of ampoule 510, into sleeve502, through ports 1028 a, and out through channels 506 a of manifold506.

As wound treatment material “W” is dispensed from applicator 500, woundtreatment material “W” is deposited on first intestinal section “T1”.Preferably, wound treatment material “W” is deposited completely aroundfirst intestinal section “T1” and/or second intestinal section “T2”. Incertain embodiments, the wound treatment material is dispensed outwardlyfrom the manifold 506. In other embodiments, the wound treatmentmaterial is dispensed in a distal and/or proximal direction from themanifold 506, depending on the location of the channels 506a.

Following dispensing of the wound treatment material onto firstintestinal section “T1” and/or second intestinal section “T2”, anvilmember 1026 and tubular body portion 1022 are further approximated toapproximate first intestinal section “T1” and second intestinal section“T2” into contact with one another. The manifold is accommodated in therecess 1020 b. The rotatable grip member 1018 is once again used toapproximate the anvil member 1026 and tubular body portion 1022. Whenfirst intestinal section “T1” is in contact with second intestinalsection “T2”, the wound treatment material is sandwiched therebetween.

Surgical stapling apparatus 1000 may then be fired by operating handlemember 1012, thereby stapling first intestinal section “T1” to secondintestinal section “T2”. Upon firing of surgical stapling apparatus1000, the staples are expelled from distal end 1022 of body portion 1020by the staple pusher member (not shown) and driven through first andsecond intestinal sections “T1 and T2”. Additionally, an annular knife,disposed radially inward of the staple pockets 1024, severs theintestinal tissue radially inwardly of the staple pockets 1024, tothereby complete the anastomosis. In other embodiments, the woundtreatment material is dispensed after the approximation and/or firing ofstaples.

In an alternate method, it is envisioned that the surgical anastomosisprocedure may be accomplished without staples. Accordingly, followingdispensing of the wound treatment material onto first intestinal section“T1” and/or second intestinal second “T2”, anvil member 1026 isapproximated toward distal end 1022 of body portion 1020 until firstintestinal second “T1” contacts second intestinal section “T2” therebysqueezing the wound treatment material therebetween. Depending on theparticular wound treatment material (e.g., adhesive) used, anvil member1026 is maintained approximated against distal end 1022 of body portion1020 for a time sufficient for the wound treatment material to cure andbegin to adhere first intestinal section “T1” and second intestinalsection “T2” with one another. The choice of the wound treatmentmaterial (e.g., adhesive) will determine the time required to maintainanvil member 1026 approximated against distal end 1022 of body portion1020.

From the foregoing, it will be appreciated that the structures of thepresent disclosure function to strengthen the anastomosis and reduce theoccurrence of bleeding, leaking and stricture. It is also to beappreciated that the structures of the present disclosure may beutilized in a number of other applications and is not limited solely tobowel or bronchus anastomosis.

In further embodiments, the structures disclosed above are utilized toadhere the intestinal sections to one another without the use ofstaples. The adhesive material carried by or incorporated in the bodyportion of the structure joins the intestinal sections and may alsoprovide a seal against leakage. The device 10 is utilized to approximatethe intestinal sections and dispose the structure between the intestinalsections, except that the device 1000 need not house staples therein.

Each structure described above is constructed to deliver a predeterminedamount of wound treatment material to the target surgical site. Theamount of material to be delivered is site specific. Accordingly,different sized (e.g., different thickness or different volume)structures are contemplated for retaining a different volume or quantityof adhesive therein. In this manner, depending on the particular needand the particular surgical procedure, the surgeon may select astructure containing the needed and/or desired volume or quantity ofadhesive therein.

While several particular forms of the structures have been illustratedand described, it will also be apparent that various modifications canbe made without departing from the spirit and scope of the presentdisclosure. For example, it is envisioned and within the scope of thepresent disclosure for an energy-activated wound treatment material,such as, an ultraviolet light activated adhesive, to be used inconnection with any of the structures described above. In use, eitherprior to or following firing of surgical stapling device 10, energy isapplied to the structure. For example, a structure including a UVlight-curable adhesive is irradiated with UV light to thereby activatethe adhesive.

According to one aspect of the present disclosure, an assembly fordisposing a support structure between intestinal sections is provided.The assembly includes an annular surgical stapling device, having ananvil assembly and a tubular body portion. The anvil assembly has ananvil member and a first shaft. The tubular body portion carries aplurality of surgical staples in an annular configuration. The tubularbody portion has a second shaft disposed radially inward of the surgicalstaples. The first shaft of the anvil member is attachable to the secondshaft of the tubular body. The assembly further includes a supportstructure having a generally centrally located aperture for beingdisposed on one of the first shaft and the second shaft. The supportstructure includes a material selected from the group consisting of atleast one of an adhesive, a sealant, a hemostat, and a medicament.

The support structure is impregnated with the material. The supportstructure includes an inflatable annular structure and is deployablefrom a first collapsed position to a second expanded position. Wherein,when in the expanded position, the support structure has a toroidalshape defining an interior space for receiving the material. The annularstructure may include a circular tube and a plurality of spokesextending radially inwardly from the circular tube. The interior spaceof the support structure contains the material.

The material may include a first part of a two-part adhesive and isdisposed in a first chamber of the interior space of the supportstructure. A second part of the two-part adhesive is disposed in asecond chamber of the interior space of the support structure. The firstpart and second part of the material is released from the supportstructure upon deployment of the staples. The staples may have a secondpart of the two-part adhesive.

The support structure includes a shape memory material and is deployablefrom a first collapsed position to a second expanded position. Thesupport structure includes a shape memory alloy.

The support structure may include a first layer and a second layer. Thefirst layer includes a first part of a two-part adhesive and the secondlayer includes a second part of the two-part adhesive.

The support structure may include a first part of a two-part adhesiveand a second part of the two-part adhesive may include a liquid to beapplied to the support structure.

According to another aspect of the present disclosure, a method ofdisposing a structure between tissue sections is provided. The methodincludes the steps of providing a surgical stapling device having ananvil assembly and a body portion. The anvil assembly has an anvilmember and the body portion carrying a plurality of surgical staples anda knife. The method further includes the steps of inserting the anvilassembly into a first tissue section; inserting the body portion in asecond tissue section; and disposing a support structure between thefirst tissue section and the second tissue section, the annularstructure including a wound treatment material. The method furtherincluding the steps of approximating the anvil assembly and body portionwith one another so that an end portion of the first tissue section, anend portion of the second tissue section and the support structure aredisposed between the anvil member and the body portion, the supportstructure being disposed between the first tissue section and the secondtissue section; deploying the staples from the body portion; and cuttingthe first tissue section and the second tissue section with the knife.

The anvil assembly may have a first shaft and the body portion may havea second shaft, wherein the first shaft is attachable to the secondshaft. The method further including the step of attaching the firstshaft to the second shaft before the step of approximating.

The support structure may have an annular shape and include a generallycentrally located aperture. The method further includes the step ofinserting one of the first shaft and the second shaft into the aperturebefore the step of attaching the first shaft to the second shaft. Thesupport structure may be disposed on one of the first shaft and thesecond shaft before the step of approximating.

The support structure includes a shape memory material and is deployablefrom a first collapsed position to a second expanded position. Thesupport structure is deployed from the first position to the secondposition before the step of approximating.

The support structure includes an interior space housing a woundtreatment material. The wound treatment material is deployed from theinterior space upon deployment of the staples.

The wound treatment material is selected from the group consisting of anadhesive, a sealant and a medicament.

The method further includes the step of deploying an adhesive material.The support structure may include a first layer and a second layer. Thestep of deploying an adhesive material may include contacting the firstlayer and the second layer. The support structure may include a firstpart of a two-part adhesive. Accordingly, the step of deploying anadhesive material may include deploying a second part of the two-partadhesive before the step of approximating. The step of deploying anadhesive material includes puncturing the support structure, wherein thesupport structure having an interior space containing an adhesivetherein.

According to a further aspect of the present disclosure, an assembly forjoining tissue is provided. The assembly includes an anvil and a bodyportion juxtaposed with respect to one another along a shaft andarranged so as to be approximated with respect to one another; and asupport structure including a resilient material.

The support structure may include a mesh-like material and the resilientmaterial is woven into the mesh of the support structure. The supportstructure includes a first layer and a second layer. The resilientmaterial may be disposed between the first layer and the second layer.

The first layer of the support structure includes a first part of atwo-part wound treatment material, and the second layer of the supportstructure includes a second part of the two-part wound treatmentmaterial.

The support structure includes a first part of a two-part woundtreatment material and a second part of the two-part wound treatmentmaterial may include a liquid to be applied to the support structure.

According to one aspect of the present disclosure, an assembly forjoining tissue is provided. The assembly includes an anvil and a bodyportion juxtaposed with respect to one another along a shaft andarranged so as to be approximated with respect to one another; and asupport structure on the shaft, the support structure defining a cavityfor containing a wound treatment material therein. The support structuremay be bio-absorbable.

The body portion may carry a plurality of surgical staples in a circularconfiguration. The surgical staples are deployable against the anvil.The assembly further includes an annular knife disposed radiallyinwardly of the staples.

The support structure includes an inflatable circular tube. The supportstructure is deployable from a first collapsed condition to a secondexpanded condition. The shaft includes at least on port in communicationwith the cavity for delivering wound treatment material. The woundtreatment material expands the support structure from a first collapsedcondition to a second expanded condition. The interior space of thecircular tube defines a first chamber for receiving a first part of atwo-part wound treatment material. The interior space of the circulartube defines a second chamber for receiving a second part of thetwo-part wound treatment material.

The plurality of surgical staples may have a second part of the two-partwound treatment material.

A support structure for use with an annular stapling apparatus inperforming an anastomosis is provided. The support structure includes adisk shaped body portion having an upper surface, a lower surface, anouter terminal edge, and an inner terminal edge defining an aperturetherein, the body portion defining a central axis through the aperture;and a first and a second membrane extending radially outward from theouter terminal edge of the body portion.

The inner terminal edge of the body portion extends radially inward ofan inner radial edge of a staple cartridge assembly of the staplingapparatus when the support structure is positioned on a shaft of ananvil assembly of the stapling apparatus. The aperture of the bodyportion is dimensioned to receive a shaft of an anvil assembly.

Each of the first and second membranes is made from a polymeric film.

Desirably, each of the first and second membranes is made frompolyethylene.

The support structure may have an undeployed condition wherein the firstand second membranes are rolled-up towards the body portion, and adeployed condition wherein the first membrane extends in a substantiallydistal direction from the body portion and the second membrane extendsin a substantially proximal direction from the body portion.

The support structure further includes a rip-cord rolled-up into each ofthe first and second membranes when the support structure is in theundeployed condition. Each rip-cord includes a free end extending fromthe rolled-up membranes when the support structure is in the undeployedcondition. Accordingly, pulling on a rip-cord causes a respective one ofthe first and second membranes to un-roll. Each of the first and secondmembranes extends approximately 2.0 cm when un-rolled.

Each membrane includes a first inner layer and a second outer layer. Thesecond outer layer of each membrane swells at a rate greater than thefirst inner layer.

The support structure may have an undeployed condition wherein the firstand the second membranes extend substantially radially outward from thebody portion, and a deployed condition wherein the first membraneextends in a substantially distal direction from the body portion andthe second membrane extends in a substantially proximal direction fromthe body portion. Accordingly, when the support structure is in theundeployed condition, the second outer layers of the first and secondmembranes are in juxtaposed relation to one another.

The second outer layers of the first and second membranes are made froma hydrogel. The first inner layer of each of the first and secondmembranes is constructed from a substantially non-absorbable material.The first inner layer of each of the first and second membranes isfabricated from a bio-absorbable mesh fabric. Accordingly, when thesupport structure is positioned on a shaft of an anvil assembly and theanvil assembly is approximated toward a staple cartridge assembly, thesupport structure is disposed between adjacent tissue sections to beanastomosed. Additionally, when the support structure is disposedbetween the adjacent tissue sections, as second inner layers of firstand second membranes absorb moisture, the first and second membranescurl in the direction of the first inner layer of respective first andsecond membranes such that the first outer layer contacts a respectivetissue section.

According to yet another aspect of the present disclosure, a method ofdisposing a support structure between adjacent intestinal sections isprovided. The method includes the steps of providing an annular surgicalanastomosis device. The annular surgical anastomosis device includes ananvil assembly having an anvil member and a first shaft; and a tubularbody portion having an annular knife operatively disposed therein and asecond shaft disposed radially inward of the annular knife. The firstshaft of the anvil assembly is selectively attachable to the secondshaft of the tubular body.

The method further includes the steps of inserting the anvil assemblyinto a first intestinal section; inserting the tubular body portion intoa second intestinal section; disposing a support structure between thefirst intestinal section and the second intestinal section;approximating the anvil assembly and tubular body portion with oneanother so that an end portion of the first intestinal section, thesupport structure, and an end portion of the second intestinal sectionare disposed between the anvil member and the tubular body portion, thesupport structure being disposed between the first intestinal sectionand the second intestinal section; and firing the surgical anastomosisdevice to sever the portions of the first and second intestinal sectionsdisposed radially inward of the annular knife, and to touch the portionsof the first and second intestinal sections radially outward of theannular knife against the support structure.

The anvil assembly may include a first shaft and the tubular bodyportion may include a second shaft disposed radially inward of theannular knife. The first shaft of the anvil member may be attachable tothe second shaft of the tubular body portion. The method may furtherinclude the step of attaching the first shaft of the anvil assembly tothe second shaft of the tubular body portion prior to the step ofapproximating the anvil assembly to the tubular body portion.

The support structure may include an aperture formed therein.Accordingly, the method may further include the step of inserting one ofthe first shaft of the anvil assembly and the second shaft of thetubular body portion into the aperture of the support structure prior tothe step of attaching the first shaft of the anvil assembly to thesecond shaft of the tubular body portion.

The tubular body portion may carry a plurality of surgical staples in acircular configuration. The surgical staples are disposed radiallyoutward of the annular knife. Accordingly, upon firing of theanastomosis device, the plurality of staples penetrate a firstinterstitial section, the support structure and then a secondinterstitial section.

Desirably, the step of firing the surgical anastomosis device includesdriving the plurality of staples from the tubular body portion throughthe second intestinal section, through the support structure, throughthe first intestinal section, and against the anvil member.

The support structure includes a disk shaped body portion having anupper surface, a lower surface, an outer terminal edge, and an innerterminal edge defining an aperture therein, the body portion defining acentral axis through the aperture; and a first and a second membraneextending radially outward from the outer terminal edge of the bodyportion. The inner terminal edge of the body portion of the supportstructure extends radially inward of an inner radial edge of a staplecartridge assembly of the stapling apparatus when the support structureis positioned on the first shaft of the anvil assembly of the surgicalanastomosis device. The aperture of the body portion of the supportstructure is dimensioned to receive the first shaft of the anvilassembly.

Each of the first and second membranes of the support structure may bemade from a polymeric film, preferably, polyethylene.

The support structure may have an undeployed condition wherein the firstand second membranes thereof are rolled-up towards the body portion, anda deployed condition wherein the first membrane extends in asubstantially distal direction from the body portion of the supportstructure and the second membrane extends in a substantially proximaldirection from the body portion of the support structure.

Desirably, a rip-cord may be rolled-up into each of the first and secondmembranes of the support structure when the support structure is in theundeployed condition. Each rip-cord may include a free end extendingfrom the rolled-up membranes when the support structure is in theundeployed condition.

The method may further include the step of pulling on each rip-cord tounroll the first and second membranes over the first and secondintestinal sections. Each of the first and second membranes of thesupport structure extends approximately 2.0 cm when un-rolled. Eachmembrane of the support structure includes a first inner layer and asecond outer layer. The second outer layer of each membrane of thesupport structure swells at a rate greater than the first inner layer.

The support structure has an undeployed condition wherein the first andthe second membranes extend substantially radially outward from the bodyportion thereof, and a deployed condition wherein the first membraneextends in a substantially distal direction from the body portionthereof and the second membrane extends in a substantially proximaldirection from the body portion thereof. Accordingly, when the supportstructure is in the undeployed condition, the second outer layers of thefirst and second membranes are in juxtaposed relation to one another.

The second outer layers of the first and second membranes are made froma hydrogel. The first inner layer of each of the first and secondmembranes of the support structure is constructed from a substantiallynon-absorbable material. The first inner layer of each of the first andsecond membranes is fabricated from a bio-absorbable mesh fabric.

The support structure is positioned on the first shaft of the anvilassembly and the anvil assembly is approximated toward the staplecartridge assembly, the support structure is disposed between adjacenttissue sections to be anastomosed.

Desirably, when the support structure is disposed between the adjacenttissue sections, as second inner layers of first and second membranesabsorb moisture, the first and second membranes curl in the direction ofthe first inner layer of respective first and second membranes such thatthe first outer layer contacts a respective intestinal section.

The first and second membranes of the support structure desirably extendapproximately 2.0 cm from the outer terminal edge of the body portion ofthe support structure.

According to yet another aspect of the present disclosure, an anvilassembly for use with and operatively connectable to an annular surgicalstapling device is provided. The anvil assembly includes an anvilmember; a shaft extending from the anvil member; and a support structureassembly operatively supported on the shaft. The support structureassembly includes a sleeve defining a chamber therein, the sleeve beingmovable along the length of the shaft; and a support structure. Thesupport structure includes a hub operatively supported on the shaft; aplurality of spokes extending from the hub; a disc supported on thespokes; and wound treatment material associated with the disc.

The sleeve is axially movable along the length of the shaft from a firstposition in which the support structure is in a collapsed condition andcontained in the chamber of the sleeve and a second position in whichthe support structure is in an expanded condition and free from thesleeve.

The spokes are fabricated from a shape memory material. The disc isfabricated from a mesh. The disc is bio-absorbable. The reinforcingmember may further include a ring connected to the spokes. The ring isfabricated from a shape memory material.

The wound treatment material is at least one of an adhesive, a sealant,a hemostat and a medicament. The adhesive is at least one of a proteinderived, aldehyde-based adhesive material, and a cyanoacrylate-basedmaterial. The sealant is at least one of a fibrin sealant, acollagen-based and synthetic polymer-based tissue sealant, a syntheticpolyethylene glycol-based sealant, and a hydrogel material. The hemostatmaterial is at least one of a fibrin-based, a collagen-based, anoxidized regenerated cellulose-based and a gelatin-based topicalhemostat, and fibrinogen-thrombin combination materials. The medicamentis at least one of a drug, an enzyme, a growth factor, a peptide, aprotein, a dye, a diagnostic agent and a hemostasis agent.

The sleeve may include a cam surface formed therein and the shaftincludes a cam follower provided thereon, wherein the cam follower isconfigured to ride in the cam surface.

It is further contemplated that each of the structures described hereinmay be used with an annular surgical anastomosing device, not includingany staples for securing tissue together, which is capable ofapproximating, adhering and cutting tissue.

Thus, it should be understood that various changes in form, detail andapplication of the structures of the present disclosure may be madewithout departing from the spirit and scope of the present disclosure.

1-46. (canceled)
 47. A surgical stapling device for joining tissueportions, comprising: a handle assembly; an anvil assembly at a distalend of the stapling device, the anvil assembly having a shaft forremovably connecting the anvil assembly to the stapling device; atubular body portion, the tubular body portion having a staple cartridgeassembly containing a plurality of surgical staples in an annular array,the anvil assembly and tubular body portion being juxtaposed withrespect to one another along the shaft and arranged so as to beapproximated with respect to one another; and an applicator supported onthe shaft of the anvil assembly, the applicator having a disc-shapedstructure disposed between the anvil member and tubular body portion,the disc-shaped structure having a channel radially oriented and open atlateral sides of the disc-shaped structure, the channel being arrangedfor dispensing a wound treatment material.
 48. The surgical staplingdevice according to claim 47, wherein the handle assembly includes agrip that is used to approximate the anvil assembly and tubular bodyportion.
 49. The surgical stapling device according to claim 47, whereinthe disc-shaped structure is substantially rigid.
 50. The surgicalstapling device according to claim 47, wherein the wound treatmentmaterial is at least one of an adhesive, a sealant, a hemostat, and amedicament.
 51. The surgical stapling device according to claim 47,wherein the applicator includes a sleeve operatively connected to theanvil assembly.
 52. The surgical stapling device according to claim 51,wherein the channel is in fluid communication with the sleeve.
 53. Thesurgical stapling device according to claim 52, wherein the woundtreatment material is retained within and dispensed from the sleeve. 54.The surgical stapling device according to claim 51, wherein theapplicator includes an ampoule selectively positionable within thesleeve, wherein the wound treatment material is retained within anddispensed from the ampoule.
 55. The surgical stapling device accordingto claim 47, wherein the disc-shaped structure includes a manifoldsupported on the anvil assembly, wherein the manifold defines thechannels therein for directing a flow of wound treatment material ontoan interface between the tissue portions.
 56. The surgical staplingdevice according to claim 53, wherein the channel is in fluidcommunication with the sleeve.
 57. The surgical stapling deviceaccording to claim 47, wherein the applicator includes a seal.
 58. Thesurgical stapling device according to claim 47, further comprising anannular knife disposed radially inwardly of the staples.
 59. Thesurgical stapling device according to claim 54, wherein the shaft andthe sleeve form a plunger for compressing the amouple and dispensing thewound treatment material.
 60. The surgical stapling device according toclaim 51, wherein the sleeve includes a portion through which theinterior of the tubular sleeve is visible.
 61. The surgical staplingdevice according to claim 60, wherein the sleeve selectively engages aconnection member of the surgical stapling device.
 62. The surgicalstapling device according to claim 51, wherein the disc-shaped structureis supported on the distal end of the sleeve.